(88 days)
Defibrillation is a means of terminating ventricular fibrillation and ventricular tachycardia. The biphasic waveform used in this device has only been clinically tested on adults; it has not been tested on pediatric patients. The AED mode is for use on patients in cardiopulmonary arrest. Pacing is used to treat symptomatic bradycardia and asystole. ECG monitoring is used for identifying and diagnosing cardiac rhythms and dysrhythmias and calculating heart rate. Pulse oximetry is used to check the saturation of in the arterial blood of patients who are at risk of developing hypoxemia.
The LIFEPAK 12 defibrillator/monitor series is a complete acute cardiac response system - battery or auxiliary powered defibrillator (manual and AED), monitor, pacemaker, 3 lead ECG, interpretive 12 lead ECG and pulse oximeter. Data can be transmitted by landline or cell phone to computer, fax, printer, or ECG storage system
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provided does not contain specific, quantifiable acceptance criteria or a direct table comparing them to reported device performance. The entire summary focuses on demonstrating "substantial equivalence" rather than meeting pre-defined performance metrics through a detailed study report.
However, based on the description, the core "performance" being highlighted is the efficacy of the Biphasic Truncated Exponential (BTE) waveform for defibrillation.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Efficacy in Defibrillation | The efficacy of the Physio-Control BTE waveform was demonstrated in a multi-site clinical study. The results of that study are reported in the 510(k). (Specific quantitative results, such as success rate or first-shock success, are not provided in this summary but are stated to be in the full K991910 submission.) |
| Safety | Compliance to applicable sections of ANSI/AAMI DF2 1989, Cardiac Defibrillator Devices Standard, and ANSI/AAMI DF39 1993, Automatic External Defibrillator Standard. This information demonstrates that the LIFEPAK 12 is substantially equivalent to the predicate devices with respect to safety, effectiveness, and performance. |
| Performance | Compliance to applicable sections of ANSI/AAMI DF2 1989, Cardiac Defibrillator Devices Standard, and ANSI/AAMI DF39 1993, Automatic External Defibrillator Standard. This information demonstrates that the LIFEPAK 12 is substantially equivalent to the predicate devices with respect to safety, effectiveness, and performance. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided text. The document only mentions a "multi-site clinical study" for the efficacy of the BTE waveform.
- Data Provenance: Not explicitly stated. It refers to a "multi-site clinical study," which generally implies prospective data collection, but no details on the specific countries or retrospective/prospective nature are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable/not mentioned. This device (a defibrillator) does not rely on human interpretation of outputs to establish ground truth in the same way an AI diagnostic tool would. The efficacy (success of defibrillation) would be measured by physiological outcomes.
- Qualifications of Experts: Not applicable/not mentioned.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable/not mentioned. As above, this device's performance is measured by its direct physiological effect (e.g., termination of arrhythmia), not by human interpretation requiring consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a manual and automated external defibrillator/monitor/pacemaker, not an AI-assisted diagnostic tool that would improve human reader performance. Its function is to deliver therapy and monitor physiological signals.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance: The core efficacy evaluation described relates to the Biphasic Truncated Exponential (BTE) waveform of the defibrillator itself, not a separate "algorithm only" performance for an interpretive component. While the device has an "Interpretive 12-lead ECG," the study described specifically addresses the defibrillation waveform. The AED mode certainly has an algorithm for rhythm analysis, but its standalone performance metrics are not detailed, beyond stating it "analyzes the patient's ECG rhythm." The clinical study mentioned focuses on the biphasic waveform efficacy.
7. The Type of Ground Truth Used:
- Type of Ground Truth: For the defibrillation efficacy study, the ground truth would be clinical outcomes data related to the termination of ventricular fibrillation and ventricular tachycardia. This would likely involve observing the patient's rhythm post-shock.
8. The Sample Size for the Training Set:
- Sample Size: Not applicable/not mentioned. This device's core claim (biphasic waveform efficacy) is based on fundamental physiological principles and prior clinical validation, not on a machine learning model that requires a training set in the conventional sense. While the AED component has an algorithm, no details on its training were provided.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable/not mentioned, as there is no explicitly defined "training set" for an AI model. For the AED algorithm, the "ground truth" for training would likely involve expert-labeled ECG rhythms (e.g., cardiologists classifying rhythms as shockable/non-shockable) if it were a machine learning algorithm. However, this is not detailed in the provided text.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.